CoMMpass to multiple myeloma treatment
NORWALK, Conn.—The Multiple Myeloma Research Foundation (MMRF) has announced a partnership with US Oncology Research to undertake a landmark, long-term clinical study of multiple myeloma's (MM) natural history and its effects on the body at the molecular level.
MM is an incurable cancer of the blood. An estimated 20,000 new cases are diagnosed every year, and close to 100,000 patients are currently living with the disease.
According to Dr. Robert Rifkin, oncologist and hematologist at Rocky Mountain Cancer Centers, which is affiliated with US Oncology Research, 20 years ago, survivability among those diagnosed with multiple myeloma was very poor—perhaps two to three years.
"Fortunately, during the past couple of decades, we've gained access to a host of new agents, including proteasome drug classes and stem cell transplants," he says. "We've improved patient survivability to 10 years or more in some cases."
Medical science still has a long way to go, however. It has yet to be able to fully analyze the natural history of MM. Part of what makes the disease so difficult to understand and treat is the fact that it arises from multiple malignancies rather than from a single illness or event—for example, toxic exposure followed by an infection. The combination of factors leading to the development of the illness varies from patient to patient, making a one-size-fits-all therapy that much more difficult to isolate.
Instead of looking for a single new therapy, this collaboration between MMRF and US Oncology Research will be a foray into personalized medicine, with the hope of learning the molecular and genetic changes that mark the progression of the disease and discovering ways to cater treatment to each individual case. This landmark study has been dubbed Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile, or CoMMpass, and is supported by a $40 million investment by the MMRF.
"This study is really a prototype of personalized medicine," says Dr. Carolyn Hoban, director of translational research at MMRF. "The results may someday empower physician's decision-making regarding treatment options for their patients."
"Our goal is to accrue 1,000 newly diagnosed multiple myeloma patients and to use genome sequencing to identify new targets for therapy, which could potentially lead to the development of a new drug," says Rifkin. "We would then be able to take it through development. We plan to follow the patients for a minimum of five years."
At the outset, newly diagnosed MM patients' tissues will be analyzed for quality and whole-genome sequencing. Their chromosomes will be analyzed, and DNA and RNA samples will be extracted as they begin therapy. Researchers will be able to observe these patients going forward and return information in real-time, both to the doctors and to the patients. Finally, additional sets of tissue samples will be taken at each relapse and at the time of failure of treatment, providing benchmarks that will allow researchers to observe the molecular-level changes that have occurred during the course of the disease.
The study also aims to create a "biobank" of serum and plasma that can be further analyzed to look for better biomarkers to facilitate new diagnostic and treatment options in future patients.
"We hope to discover more noninvasive diagnostic tools that will minimize the discomfort to the patient," Hoban says.
The collaboration between MMRF and US Oncology Research marries two robust partners in the fight against multiple myeloma. US Oncology Research represents a large community of MM patients and physicians, as the organization sees roughly 20 percent of all new MM cases, and has participated in 38 out of 40 U.S. Food and Drug Administration (FDA)-approved drugs. US Oncology Research is already currently involved in about 100 other open trials, and will be the principal investigator overseeing the CoMMpass study. Aside from financial sponsorship of the CoMMpass study, the Multiple Myeloma Research Foundation brings to the table the technology and the science necessary to process the tissue samples and conduct the genome sequencing and other molecular analyses.
The CoMMpass study already has two pharmaceutical partners—Millennium and Onyx—that, in exchange for financial support of the study, will receive priority access to the data it generates for a six-month window, after which the data will enter the public domain. Two or three additional pharmaceutical partners may be added to the study later.
"Our hope is that we will quickly begin generating hypotheses that can lead to clinical trials," says Anne Quinn Young, vice president of marketing at MMRF. "We're in a position to play a lead role in connecting this data to therapeutic advances."
"We need more collaborations like this between the medical and patient communities and academia," Rifkin says. "We're off to a good start."